The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir ) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus ( HCV ) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV ( treatment-naïve ).
Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis.
Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
HCV is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
According to the U.S. Centers for Disease Control and Prevention ( CDC ), an estimated 2.7 to 3.9 million people in the U.S. have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection.
Researchers estimate there are 23,000 to 46,000 children in the U.S. with HCV infection.
The efficacy and safety of Mavyret was established in clinical trials, which cumulatively evaluated more than 2,500 people with HCV genotype 1, 2, 3, 4, 5 or 6 infection who received Mavyret for eight, 12 or 16 weeks duration.
The trials included patients with HIV-co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring hemodialysis.
The efficacy of HCV treatment regimens are measured by the proportion of people in clinical trials achieving virologic cure.
Virologic cure is the lack of detectable HCV in the blood at certain time points after completion of HCV therapy, known as sustained virologic response ( SVR ).
SVR at 12 weeks post-treatment ( SVR 12 ) is the standard measure of virologic cure.
SVR 12 rates for Mavyret have ranged from 91-100% across clinical trials.
The most common adverse reactions in patients taking Mavyret are headache and fatigue.
Mavyret is contraindicated in patients with moderate or severe liver impairment ( Child-Pugh B or C ) or in those with any history of liver decompensation. It is also contraindicated in patients taking the drugs Atazanavir and Rifampin. ( Xagena )
Source: FDA, 2019